Intra-oral appliance and methods of using same

ABSTRACT

The present invention provides a system and method for correcting facial features and oral function in a subject. Also provided are a plurality of intra-oral appliances, which make up the system. The intra-oral appliances each include an appliance body configured for engaging one or more of the gingival-buccal area, the gingivolabial area, and the vestibular area of the subject&#39;s mouth, and include one or more extensions for at least partly defining the cavity in the vestibule of the subject&#39;s mouth. The appliance bodies may also include one or more dentures disposed therein and/or one or more hearing assist devices embedded therein.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application is a continuation-in-part of, and claims the benefit ofpriority to, U.S. Ser. No. 13/233,929, filed Sep. 15, 2011, the entirecontent of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates generally to an article for correcting facialfeatures and oral function, and more specifically to an intra oralmaxillofacial prosthesis and methods for treating the symptoms of facialnerve paralysis using the same.

2. Background Information

In today's society, youth is a highly prized asset. The human face is animportant element in projecting a youthful appearance, but it is alwayseventually subject to the effects of aging, which sagging cheeks, lines,wrinkles, folds, and depressions. Similarly, these effects may occurafter extreme, rapid weight loss, or as a consequence of facialparalysis from health problems such as Bell's palsy or stroke.

Bell's Palsy is a form of facial paralysis resulting from dysfunctioncranial nerve VII (the facial nerve) that results in the inability tocontrol facial muscles on the affected side. The annual incidence ofBell's palsy is about 20 per 100,000 population, and the incidenceincreases with age. Bell's palsy is defined as an idiopathic unilateralfacial nerve paralysis, usually self-limiting. The hallmark of thiscondition is a rapid onset of partial or complete palsy (paralysis) thatoften occurs overnight. In rare cases, it can occur bilaterallyresulting in total facial paralysis. Symptoms vary from person to personand can range in severity from mild weakness to total paralysis. Thesesymptoms include twitching, weakness, paralysis, drooping eyelid orcorner of the mouth, drooling, dry eye or mouth, impairment of taste,excessive tearing in the eye, and hearing loss. For most people, Bell'spalsy symptoms improve within a few weeks, with complete recovery inthree to six months. About 10 percent will experience a recurrence ofBell's palsy, sometimes on the other side of the face. A small number ofpeople continue to have some Bell's palsy signs and symptoms for life.

The resultant effects of facial paralysis include, but are not limitedto, facial distortion/disfigurement, psychological trauma, problems withmastication and eating, and the inability to smile and/or talk normally.Because oral tissues are highly sensitized, they often become irritateddue to food being trapped in the cheek of a person afflicted with facialparalysis. In addition, air bubbles accumulate in the oral vestibule onthe affected side of the mouth when speaking.

Various forms of paralysis or weakness of the unilateral or bilateralfacial muscles have been caused by injury to the facial nerve, viralinfection, bacterial infection, nerve trauma, vascular etiologies,parotidectomy, stroke, brain surgery, aging, and trauma etiologies.Because facial paralysis affects each individual differently, afflictedsubjects must seek treatments tailored to the specific symptoms thatoccur. Drugs are commonly used to treat the condition chemically, whilevarious forms of surgery attempt to transplant nerves from other areasof the face and body and/or attempt to lift drooping skin/cheeks. Inaddition, subjects afflicted with facial palsy often seek speech therapyto correct basic communication skills.

Thus, a need exists for a system that addresses the physical appearance,oral discomfort and psychological distress from the victims' physicalaffect of the traumatic neuropathy.

SUMMARY OF THE INVENTION

The present invention is based on the finding that an intra-oralprosthesis can be used to correct facial features and/or oral functionof a subject suffering from facial palsy. Provided herein are a systemand method for correcting facial features and oral function of asubject. Using accurate models of both upper and lower arches of asubject's teeth, including the full vestibular areas, the appliancesdiscussed herein are custom designed and built with regard to theindividual subject's unique dentition and oral structure. Accordingly,the systems and methods provided herein include one or more intra-oralprosthesis for the relief of symptoms and physical, psychological andsocial affect of the subject's palsy or defect.

As such, in one aspect, the invention provides an intra-oral appliancefor correcting facial features of a subject. The appliance includes anappliance body configured for engagement with a subject's upper teethand anterior palate, wherein the appliance body has one or moreextensions for engaging one or more of the gingival-buccal area and thevestibular area of the subject's mouth, thereby at least partly defininga cavity in the vestibule of the subject's mouth. In one embodiment, theappliance body has one extension for defining the vestibule at eitherside of the subject's mouth. In another embodiment, the appliance bodyhas two extensions for defining the vestibule at both sides of thesubject's mouth. In various embodiments, the appliance body may alsoinclude one or more dentures disposed therein to replace any missingteeth of the subject. In various embodiments, the appliance body mayalso include one or more hearing assist devices to restore unilateral orbilateral hearing loss through micro bone conduction transducertechnology.

In another aspect, the invention provides a system for correcting facialfeatures of a subject. The system includes an upper intra-oral appliancecomprising a first appliance body configured for engaging one or more ofthe upper gingival-buccal area, the upper gingivolabial area, and theupper vestibular area of the subject's mouth, and a lower intra-oralappliance comprising a second appliance body configured for engaging oneor more of the lower gingival-buccal area, the lower gingivolabial area,and the lower vestibular area of the afflicted side the subject's face.In one embodiment, the first appliance body is configured for engagementwith the subject's upper teeth and anterior palate, wherein the firstappliance body has one or more extensions for engaging one or more ofthe upper gingival-buccal area, the upper gingivolabial area, and theupper vestibular area of the subject's mouth. In another embodiment, thefirst appliance body is configured for engagement with the subject'supper gingiva on the afflicted side the subject's face, wherein thefirst appliance body is positioned from the maxillary midline of thesubject's upper gingiva to the farthest upper posterior tooth oredentulous buccal portion. In yet another embodiment, the firstappliance body is configured for engaging the upper gingiva where thetooth crown meets the gum line. In yet another embodiment, the firstappliance body further comprises one or more posterior lingual/palatalclaps for engaging one or more teeth of the subject. In yet anotherembodiment, the second appliance body is configured for positioning fromthe mandibular midline of the subject's lower gingival to the farthestlower posterior tooth or edentulous buccal portion. In yet anotherembodiment, the second appliance body further comprises one or moreposterior lingual/palatal claps for engaging one or more teeth of thesubject. In various embodiments, the first appliance body, secondappliance body, or both the first and second appliance bodies may alsoinclude one or more dentures disposed therein to replace any missingteeth of the subject. In various embodiments, the first appliance body,second appliance body, or both the first and second appliance bodies mayalso include one or more hearing assist devices to restore unilateral orbilateral hearing loss through micro bone conduction transducertechnology.

In another embodiment, the system further includes a third intra-oralappliance comprising a third appliance body configured for engagementwith the subject's upper gingiva on the afflicted side the subject'sface, wherein when used, the third appliance body is positioned from themaxillary midline of the subject's upper gingiva to the farthest upperposterior tooth or edentulous buccal portion, and wherein the first andthird intra-oral appliances are not used simultaneously. In variousembodiments, the third appliance body may also include one or moredentures disposed therein to replace any missing teeth of the subject.In various embodiments, the third appliance body may also include one ormore hearing assist devices to restore unilateral or bilateral hearingloss through micro bone conduction transducer technology.

In another aspect, the invention provides a system for correcting facialfeatures of a subject. The system includes a first upper intra-oralappliance comprising a first appliance body configured for engagementwith the subject's upper teeth and anterior palate, wherein the firstappliance body has one or more extensions for engaging one or more ofthe upper gingival-buccal area, the upper gingivolabial area, and theupper vestibular area of the subject's mouth, a second upper intra-oralappliance comprising a second appliance body configured for engagementwith the subject's upper gingiva on the afflicted side the subject'sface, wherein the second appliance body is positioned from the maxillarymidline of the subject's upper gingiva to the farthest upper posteriortooth or edentulous buccal portion, and a lower intra-oral appliancecomprising a third appliance body configured for engaging one or more ofthe lower gingival-buccal area, the lower gingivolabial area, and thelower vestibular area of the afflicted side the subject's face, whereinthe first upper intra-oral appliance and the second upper intra-oralappliances are not used simultaneously. In one embodiment, any of thefirst appliance body, the second appliance body, and the third appliancebody independently further comprise one or more posteriorlingual/palatal clasps for engaging one or more teeth of the subject. Invarious embodiments, the first appliance body, second appliance body,third appliance body, or any combination thereof may also include one ormore dentures disposed therein to replace any missing teeth of thesubject. In various embodiments, the first appliance body, secondappliance body, third appliance body, or any combination thereof alsoinclude one or more hearing assist devices to restore unilateral orbilateral hearing loss through micro bone conduction transducertechnology.

In another aspect, the invention provides a method for correcting facialfeatures and oral function of a subject afflicted with facial paralysison one or both sides of the face. The method includes fitting a subjectin need thereof with an intra-oral appliance, which includes anappliance body configured for engagement with a subject's upper teethand anterior palate, wherein the appliance body has one or moreextensions for engaging one or more of the gingival-buccal area, thegingivolabial area, and the vestibular area of the subject's mouth,thereby at least partly defining the cavity in the vestibule of thesubject's mouth.

In another aspect, the invention provides a method for correcting facialfeatures and oral function of a subject afflicted with facial paralysison one or both sides of the face. The method includes fitting a subjectin need thereof with an upper intra-oral appliance comprising a firstappliance body configured for engaging one or more of the uppergingival-buccal area, the upper gingivolabial area, and the uppervestibular area of the subject's mouth, and a lower intra-oral appliancecomprising a second appliance body configured for engaging one or moreof the lower gingival-buccal area, the lower gingivolabial area, and thelower vestibular area of the afflicted side the subject's face, therebyat least partly defining the cavity in the vestibule of the subject'smouth.

In one embodiment, the first appliance body is configured for engagementwith the subject's upper teeth and anterior palate, wherein the firstappliance body has one or more extensions for engaging one or more ofthe upper gingival-buccal area, the upper gingivolabial area and theupper vestibular area of the subject's mouth. In another embodiment, thefirst appliance body is configured for engagement with the subject'supper gingiva on the afflicted side the subject's face, wherein thefirst appliance body is positioned from the maxillary midline of thesubject's upper gingiva to the farthest upper posterior tooth oredentulous buccal portion. In yet another embodiment, the firstappliance body is configured for engaging the upper gingiva where thetooth crown meets the gum line. In yet another embodiment, the firstappliance body further comprises one or more posterior lingual/palatalclasps for engaging one or more teeth of the subject. In yet anotherembodiment, the second appliance body is configured for positioning fromthe mandibular midline of the subject's lower gingival to the farthestlower posterior tooth or edentulous buccal portion. In yet anotherembodiment, the second appliance body further comprises one or moreposterior lingual clasps for engaging one or more teeth of the subject.

In certain embodiments, the subject suffers from facial paralysis ordefect. In those embodiments, the facial paralysis or defect is a resultof brain surgery, glioma, brain injury, facial or dental surgery, Bell'sPalsy, neuro-injuries, aging, stroke or disease. In various embodiments,the subject may also suffer from unilateral or bilateral acousticneuroma or hearing loss. As such, any of the first appliance body,second appliance body, third appliance body, or any combination thereofalso include one or more hearing assist devices to restore unilateral orbilateral hearing loss through micro bone conduction transducertechnology. Likewise, the first appliance body, second appliance body,third appliance body, or any combination thereof may also include one ormore dentures disposed therein to replace any missing teeth of thesubject.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a frontal view of the maxillary arch and upper teeth.

FIG. 2A is a frontal view of a human maxilla and upper teeth, showingAppliance A with a single extension in place over the upper teeth.

FIG. 2B is a bottom/occlusal view of the human maxilla and upper teeth,showing Appliance A with a single extension in place over the upperteeth.

FIG. 2C is a frontal view of a human maxilla and upper teeth, showingAppliance A with two extensions in place over the upper teeth.

FIG. 2D is a frontal view of a human maxilla and upper teeth, showingAppliance A with two extensions in place over the upper teeth.

FIG. 2E is a frontal view of a human maxilla and upper teeth, showingAppliance A with a single extension and an embedded micro boneconducting hearing assist device, in place over the upper teeth.

FIG. 2F is a bottom view of the human maxilla and upper teeth, showingAppliance A with a single extension and an embedded micro boneconducting hearing assist device, in place over the upper teeth.

FIG. 2G is a frontal view of a human maxilla and upper teeth, showingAppliance A with two extensions and a pair of embedded micro boneconducting hearing assist devices, in place over the upper teeth.

FIG. 2H is a frontal view of a human maxilla and upper teeth, showingAppliance A with two extensions and a pair of embedded micro boneconducting hearing assist devices, in place over the upper teeth.

FIG. 3A is a frontal view of a human maxilla and upper teeth, showingAppliance B in place over the upper gingiva on the afflicted side of theface.

FIG. 3B is a bottom view of the human maxilla and upper teeth, showingAppliance B in place from the maxillary midline of the upper gingiva tothe farthest upper posterior tooth or edentulous buccal portion.

FIG. 3C is a frontal view of a human maxilla and upper teeth, showinganother embodiment of Appliance B in place over the upper gingiva whenthe subject is afflicted with bilateral facial palsy.

FIG. 3D is a frontal view of a human maxilla and upper teeth, showingAppliance B with an embedded micro bone conducting hearing assistdevice, in place over the upper gingiva on the afflicted side of theface.

FIG. 3E is a bottom view of the human maxilla and upper teeth, showingAppliance B with an embedded micro bone conducting hearing assistdevice, in place from the maxillary midline of the upper gingiva to thefarthest upper posterior tooth or edentulous buccal portion.

FIG. 3F is a frontal view of a human maxilla and upper teeth, showingAppliance B with an embedded micro bone conducting hearing assistdevice, in place over the upper gingiva.

FIG. 4A is a frontal view of the human mandible and lower teeth, showingAppliance C in place over the lower gingiva on the afflicted side of theface.

FIG. 4B is a top view of the human mandible and lower teeth, showingAppliance C in place from the mandibular midline of the lower gingiva tothe farthest lower posterior tooth or edentulous buccal portion.

FIG. 4C is a frontal view of a human mandible and lower teeth, showinganother embodiment of Appliance C in place over the lower gingiva whenthe subject is afflicted with bilateral facial palsy.

FIG. 4D is a frontal view of the human mandible and lower teeth withposterior teeth missing, showing Appliance C with denture teeth, inplace over the lower labial anatomy and buccal gingival edentulousridge.

FIG. 4E is a lingual view from the tongue of a patient afflicted withunilateral or bilateral facial paralysis and missing posterior teeth.

DETAILED DESCRIPTION OF THE INVENTION

Before the present systems, devices, and methods are described, it is tobe understood that this invention is not limited to particular devices,methods, and experimental conditions described, as such devices,methods, and conditions may vary. It is also to be understood that theterminology used herein is for purposes of describing particularembodiments only, and is not intended to be limiting, since the scope ofthe present invention will be limited only in the appended claims.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural references unless the contextclearly dictates otherwise. Thus, for example, references to “themethod” includes one or more methods, and/or steps of the type describedherein which will become apparent to those persons skilled in the artupon reading this disclosure and so forth.

The term “comprising,” which is used interchangeably with “including,”“containing,” or “characterized by,” is inclusive or open-ended languageand does not exclude additional, unrecited elements or method steps. Thephrase “consisting of” excludes any element, step, or ingredient notspecified in the claim. The phrase “consisting essentially of” limitsthe scope of a claim to the specified materials or steps and those thatdo not materially affect the basic and novel characteristics of theclaimed invention. The present disclosure contemplates embodiments ofthe invention devices and methods corresponding to the scope of each ofthese phrases. Thus, a device or method comprising recited elements orsteps contemplates particular embodiments in which the device or methodconsists essentially of or consists of those elements or steps.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the invention, the preferred methods andmaterials are now described.

The present invention is based on the finding that an intra-oralprosthesis can be used to correct facial features and/or oral functionof a subject suffering from facial palsy. Thus, provided herein is asystem for correcting facial features of a subject. The system includesone or more intra-oral appliances, which can be used simultaneously orindividually by a subject to at least partially define the cavity in thevestibule of the subject's mouth. In one embodiment, the system includestwo or more intra-oral appliances. In another embodiment, the systemincludes three or more intra-oral appliances, which hereinafter will bereferred to as Appliance A, Appliance B, and Appliance C, as discussedbelow.

Each of Appliances A-C are custom fit to each subject by making a moldor dental impression of the upper and lower teeth and palate. Theappliances are then made using any of commonly used biocompatible dentalmaterials such as, but not limited to, polyurethane, polycarbonate,heat- or cold-cured acrylics, fibered acrylic plastic, thermoplasticpolyurethane, flexible polymers, any suitable chemically activated orlight activated materials that cure to solid form, or any combinationthereof. Thus, suitable biocompatible dental plastics from whichAppliances A-C may be made include, but are not limited to,thermoplastics, polyethylene, polystyrene, polyvinyl chloride,polytetrafluoroethylene, acrylics, polyesters, silicones, polyurethanes,and/or halogenated plastics or the like. In various embodiments,Appliances A-C may molded or laminated from multiple layers of one ormore of the biocompatible dental materials, depending on the needs ofthe user. In other embodiments, Appliances A-C may have a solid core,such as a biocompatible metal, surrounded by the one or morebiocompatible dental materials. In yet other embodiments, the materialsfrom which Appliances A-C may be made, can be clear or colored,depending on the needs of the user. In one embodiment, any or all ofAppliances A-C are made from ethylene vinyl acetate, either alone or incombination with any other biocompatible dental material.

Referring now to FIG. 1, there is shown a human maxilla 10 with upperteeth 11. As shown, the cheek 13 is pulled away from the maxillaexposing a hollow space within the gingival-buccal area 14 of thevestibule of the mouth into which air can become trapped in subjectshaving facial palsy. During normal speech of persons not having a facialpalsy, the enervated muscle within cheek 13 forces air fromgingival-buccal area 14. Also shown is gingival firm tissue 16 coveringthe bony structure of the maxilla and the roots (not shown) of the upperteeth 11. The gingival firm tissue 16 typically has one or more smallprotuberances or projections (papilla) 12 on the surface thereof.

As used herein, the term “gingiva” refers to the gums of a subject. Asused herein, the term “buccal” is used to refer to the cheek or sides ofthe mouth. Thus, the term “gingival-buccal area” of a subject refers tothe area within a subject's mouth that is defined by the gums and thecheek.

As used herein, the term “labium” refers to the lip of a subject. Thus,the term “gingivolabial area” refers to the area within a subject'smouth that is defined by the gums and the inner surface of the lips.

As used herein, the term “vestibule” refers any of various cavities orhollows within the mouth of subject. Thus, the term “vestibular area” isused to refer to any cavity or hollow within the subject's mouth that islocated within the gingival-buccal areas and/or the gingivolabial areasof the mouth.

Referring now to FIGS. 2A and 2B, there is shown an embodiment ofintra-oral Appliance A, which includes an appliance body 22 fitted overthe upper teeth 11 of a human maxilla 10. The appliance body 22 may begenerally configured like a prior art orthodontic retainer, and can bemade of hard or soft plastic or other suitable materials. Body 22 fitssnugly against and covers the anterior palate, or roof of the mouth, andis generally U-shaped (as shown in FIG. 2B). Body 22 is custom-fitted tofit over the subjects upper teeth in the same manner as an occlusalnight guard, which uses occlusal coverage to hold the appliance body 22firmly onto the upper teeth of the subject. Depending on the severity ofthe subject's facial palsy, body 22 may have a thicker portion 24, whichbegins at the maxillary midline A-A of the subject's upper gingiva andextends to the farthest upper posterior tooth or edentulous buccalportion. It should be understood that the thickness of thicker portion24 may not be constant, and in most instances, can resemble thethickness of body 22 at the maxillary midline and increase to itsthickest point at the farthest upper posterior tooth or edentulousbuccal portion of the mouth. Thicker portion 24 includes at least oneextension 26 for engaging one or more of the upper gingival-buccal area,the upper gingivolabial area, and the upper vestibular area of thesubject's mouth. Thus, extension 26 defines the cavity in the vestibuleof the subject's mouth on the side afflicted with facial palsy.

FIGS. 2C and 2D show embodiments of intra-oral Appliance A for use whenthe subject is afflicted with bilateral facial palsy. FIG. 2C shows body22 with two extensions 26 for engaging the upper gingival-buccal area,the upper gingivolabial area, and the upper vestibular area on bothsides of the subject's mouth. In this embodiment, body 22 does not haveone or more thicker portions 24, but rather, extensions 26 extenddirectly from body 26. FIG. 2D shows an embodiment wherein body 22 isconfigured with two thicker portions 24, the extensions 26 of whichwould be used to engage the upper gingival-buccal areas, the uppergingivolabial areas, and/or the upper vestibular areas on both sides ofthe subject's mouth.

In most instances, body 22 is held in place by engagement with the upperteeth and anterior palate of the subject. However, in certainembodiments, body 22 can have one or more posterior lingual/palatalclasps (not shown), which are usually made of stainless steel, forengaging one or more of the subject's teeth and/or existing dentures. Itshould be understood that any of the intra-oral clasps known in the artfor dental appliances may be integrated into body 22 for additionalsecurity of the device when worn by the subject. Exemplary claspsinclude, but are not limited to c-clasps, which are placed over andsurround a molar, ball clasps, which are placed between teeth and have aball on the gingival side for securing the appliance in place, andAdams' clasps, which are formed wire clasps of modified arrowhead designusing the buccomesial and distoproximal undercuts of a tooth forretention.

Referring now to FIGS. 3A and 3B, there is shown an embodiment ofintra-oral Appliance B, which includes an appliance body 32 fitted overthe upper teeth 11 of a human maxilla 10. The appliance body 32 may begenerally configured like a prior art orthodontic retainer, and can bemade of hard or soft plastic or other suitable materials. Body 32 isconfigured for engaging the upper gingiva where the tooth crown meetsthe gum line on the afflicted side of the subject's face. Body 32 isconfigured for positioning from the maxillary midline A-A of thesubject's upper gingiva to the farthest upper posterior tooth oredentulous buccal portion of the subject's mouth, and includes at leastone extension 34 for engaging one or more of the upper gingival-buccalarea, the upper gingivolabial area, and the upper vestibular area of thesubject's mouth. The at least one extension 34 defines the cavity in thevestibule of the subject's mouth on the side afflicted with facialpalsy.

FIG. 3C shows an embodiment of intra-oral Appliance B for use when thesubject is afflicted with bilateral facial palsy. In this embodiment,body 32 is configured for fitment over all of the subject's upper teeth(similar to a conventional dental retainer) with extensions 34 definingthe cavities in the vestibule on both sides of the subject's mouth. Inanother embodiment, body 32 may have one or more thicker portions (notshown) for further correcting facial features and/or oral function ofthe subject. It should be understood that in certain instances, morethan one intra-oral Appliance B (as shown in FIGS. 3A and 3B) may beworn by the user, rather than the single bilateral embodiment shown inFIG. 3C, to engage the upper gingival-buccal areas, the uppergingivolabial areas, and/or the upper vestibular areas on both sides ofthe subject's mouth.

In various embodiments, body 32 is held in place by one or moreposterior lingual/palatal clasps 36 and 38 (as shown in FIG. 3B), whichare usually made of stainless steel, for engaging one or more of thesubject's teeth and/or dentures. Exemplary clasps include, but are notlimited to c-clasps 36, which are placed over and surround a molar, ballclasps 38, which are placed between teeth and have a ball on thegingival side for securing the appliance in place, and Adams' clasps(not shown). In most instances, such posterior lingual/palatal claspsare embedded within body 32 at the time that the body is formed.

It should be understood that Appliance A and Appliance B are notintended to be worn simultaneously by the subject. When a subject isprescribed or otherwise obtains a system in which both Appliance A andAppliance B are provided, the subject may select the Appliance that bestsuit's the needs of the user. For example, the subject may find thatAppliance A is more comfortable for daily usage, but Appliance B ispreferable for social occasions because it is less noticeable and morenatural looking when worn.

Referring now to FIGS. 4A and 4B, there is shown an embodiment of lowerintra-oral Appliance C, which includes an appliance body 42 fitted overthe lower teeth 41 of a human mandible 40. The appliance body 42 may begenerally configured like a prior art orthodontic retainer, and can bemade of hard or soft plastic or other suitable materials. Body 42 isconfigured for engaging the lower gingiva where the tooth crown meetsthe gum line on the afflicted side of the subject's face. Body 42 isfurther configured for positioning from the mandibular midline B-B ofthe subject's lower gingiva to the farthest lower posterior tooth oredentulous buccal portion of the subject's mouth, and includes at leastone extension 44 for engaging one or more of the lower gingival-buccalarea, the lower gingivolabial area, and the lower vestibular area of thesubject's mouth. The at least one extension 44 defines the lower cavityin the vestibule of the subject's mouth on the side afflicted withfacial palsy.

FIG. 4C shows an embodiment of intra-oral Appliance C for use when thesubject is afflicted with bilateral facial palsy. In this embodiment,body 42 is configured for fitment over all of the subject's lower teeth41 (similar to a conventional dental retainer) with two extensions 44defining the cavities in the lower vestibules on both sides of thesubject's mouth. In another embodiment, body 42 may have one or morethicker portions (not shown) for further correcting facial featuresand/or oral function of the subject. It should be understood that incertain instances, more than one intra-oral Appliance C (as shown inFIGS. 4A and 4B) may be worn by the user, rather than the singlebilateral embodiment shown in FIG. 4C, to engage the lowergingival-buccal areas, the lower gingivolabial areas, and/or the lowervestibular areas on both sides of the subject's mouth.

In various embodiments, body 42 is held in place by one or moreposterior lingual clasps 46 and 48 (shown in FIGS. 4A and 4B), which areusually made of stainless steel, for engaging one or more of thesubject's teeth and/or dentures. Exemplary clasps include, but are notlimited to c-clasps 46, which are placed over and surround a molar, ballclasps 48, which are placed between teeth and have a ball on thegingival side for securing the appliance in place, and Adams' clasps(not shown). In most instances, such posterior lingual/palatal claspsare embedded within body 42 at the time that the body is formed.

When a subject is prescribed or otherwise obtains a system in whichAppliances A, B and C are provided, the subject may select anycombination of Appliances that best suit's the needs of the user. Forexample, the subject may find that Appliance A in combination withAppliance C sufficiently corrects facial features and oral function fordaily usage, but Appliance B in combination with Appliance C ispreferable for social occasions because, as indicated above, Appliance Bis less noticeable and more natural looking when worn than Appliance A.

Accordingly, in another aspect, the invention provides a method forcorrecting facial features and oral function of a subject. The methodincludes fitting a subject in need thereof with one or more of theintra-oral appliance defined above. As used herein, the term “subject”refers to any individual or patient to which the subject methods areperformed. Generally the subject is human, although as will beappreciated by those in the art, the subject may be an animal that isused as a model for facial palsy. Thus other animals, including mammalssuch as rodents (including mice, rats, hamsters and guinea pigs), cats,dogs, rabbits, farm animals including cows, horses, goats, sheep, pigs,etc., and primates (including monkeys, chimpanzees, orangutans andgorillas) are included within the definition of subject.

All embodiments of Appliances A, B, and C may further include one ormore denture (i.e., false or prosthetic teeth) constructed to replaceany missing teeth of the subject. For example, as shown in FIG. 4D, thelower posterior teeth of the subject are missing. Thus, Appliance C isshown with denture teeth 50 embedded in the body 42 to replace themissing teeth of the subject. Appliance C is further shown with areinforcing metal arch bar 52 embedded into the labial section of theappliance, connecting the posterior sections thereof to strengthen theappliance for use as a prosthesis/partial denture when the subject isafflicted with unilateral or bilateral facial paralysis. Thus, in thisembodiment, there is no anterior lingual dental material. FIG. 4E is alingual view from the tongue of the subject, who is also missingposterior teeth.

Various forms of paralysis or weakness of the unilateral or bilateralfacial muscles have been caused by injury to the facial nerve, viralinfection, bacterial infection, nerve trauma, vascular etiologies,parotidectomy, stroke, brain surgery, aging, and trauma etiologies.Thus, subjects upon which the methods of the invention may be performedinclude, but are not limited to, those suffering from facial paralysisor defect. Such facial paralysis or defect may result from any one ormore of brain surgery, glioma, brain injury, facial or dental surgery,Bell's Palsy, Ramsey-Hunt syndrome, neuro-injuries, aging, stroke ordisease. Such subjects may also have one or more acoustic neuromas,which are slow-growing tumors of the nerve that connects the ear to thebrain (vestibular cochlear nerve). Because branches of this nervedirectly influence one's balance and hearing, pressure from an acousticneuroma can cause hearing loss, ringing in the ear and unsteadiness.

In addition, as humans age, the natural facial muscle tone and/or skintension lessens, thereby resulting in a slight (or in some cases severe)drooping of the cheek. Thus, the methods provided herein find use incorrecting facial features of older subjects who do not have facialpalsy.

In all instances, the definition of the upper and/or lower vestibule bythe one or more extensions of the appliance bodies described herein,serve to plump or otherwise lift and/or stretch the cheek tissue alongthe mandibular jaw and gingival ridge. This results in a straighteningof the lip line, balancing of a slacked facial aspect, and improvingoral function of the subject. Thus, the systems and intra-oralappliances described herein serve to treat oral dysfunction, physicalaffect, and psychological perception of self in a subject having facialpalsy. Abnormal speech, if present, is aided in that any air that istrapped and/or bubbling within the upper and/or lower vestibules betweenthe cheek and the gingiva on the afflicted side of the face is reducedby filling the void from lost muscle tension and allowing the air toflow over the tongue instead of being redirected to the collapsedvestibule. In addition, mastication of food is improved by preventingthe pocketing of food particles in the vestibule of the cheek. A morenatural contour of the vestibule aids in the downward drainage of salivato the occlusal surface of the mandibular arch, aiding the eliminationof oral fluids from the mouth. In certain subjects, the pooling ofsaliva can cause irritation of the gingival firm tissue, thereby causingsores on the lips and corners of the mouth.

Another complication that can arise for patients suffering from diseasesor syndromes that result in facial paralysis is unilateral, orsometimes, bilateral hearing loss. Likewise, as humans age, age-relatedhearing loss (i.e., presbycusis) may gradually appear. Hearing loss canalso be classified in terms of being conductive, sensorineural, or acombination of both. Conductive hearing impairment typically resultsfrom diseases or disorders that limit the transmission of sound throughthe middle ear. Sensorineural hearing losses occur mostly in the innerear and account for the vast majority of hearing impairment.Sensorineural hearing impairment (sometimes referred to as “nerve loss”)is largely caused by damage to the sensory hair cells inside thecochlea.

Accordingly, in various embodiments, any of the above-describedintra-oral appliances (Appliances A-C) may further include boneconduction transducer technology to provide assisted hearing to asubject in need thereof. Such bone conducting transducer hearing assistdevices are known in the art (see, e.g., U.S. Pub. Nos. 2013/0236043;2013/0236035; 2013/0003997; 2011/0280416; 2011/0081031; 2010/014689;2009/0226020; 2009/0226017; and 2009/0226011, the entire content of eachof which is incorporated herein by reference in their entireties. Seealso, U.S. Pat. Nos. 8,189,838 and 3,875,349, the entire content of eachof which is incorporated herein by reference in their entireties). Anexemplary electrical block diagram depicting the electrical componentsas used with a hearing assist device is shown in FIG. 4 of U.S. Pat. No.8,189,838.

Briefly, when any of the intra-oral appliances include such a hearingassist device 60, the appliance may include an actuator to provide boneconduction sound transmission; a transceiver coupled to the actuator tocause the actuator to generate sound; and a power supply to provideelectrical power to each of the actuator and transceiver. The actuatormay be disposed in a position of the appliance such that it ispositioned near the subject's teeth when the appliance is worn. Theactuator is driven by an electronic driver. A wireless transceiverprovides sound information to the electronic driver so that the drivercan actuate the actuator to cause sound to be generated and conducted tothe subject's ear through bone conduction. Thus, the electronic driverand actuator assembly may receive incoming sounds either directly orthrough a receiver to process and amplify the signals and transmit theprocessed sounds via a vibrating transducer element coupled to a toothor other bone structure, such as the maxillary, mandibular, or palatinebone structure.

In various embodiments, the power supply may be a battery housed withina serviceable waterproof battery compartment such that the battery maybe easily replaced and/or recharged as necessary. However, in certainembodiments, the power supply may include an electromagnetic loop with acharging coil to charge the intra-oral appliance. Such battery chargingsystems are known in the art (see, e.g., U.S. Pub. Nos. 2012/0235632 and2010/0194333, the entire content of each of which is incorporated hereinby reference in their entireties). Briefly, the battery charging systemmay include a first coil portion located on a charger base and a secondcoil portion located on or within the intra-oral appliance. When thesubject needs to recharge the battery in the intra-oral appliance, thesubject simply places the second coil portion between two ends of thefirst coil portion to complete the magnetic flux loop. The completion ofthe loop in turn induces current flow on the second coil portion. Thecurrent flow is then regulated and used to charge the battery containedtherein.

In various embodiments, the intra-oral appliance may further include acharging system disposed within the appliance body. Such a chargingsystem may rely upon the movement of a subject's head and/or mandible toprovide an electrical current to the battery. Such kinetic-basedrecharging systems are known in the art (see, e.g., U.S. Pub. No.2012/0319404, incorporated herein by reference in its entirety).Briefly, a plastic or other non-ferrous-material bobbin (or abarrel/tube, providing a magnetic chamber defining a sliding travel pathfor a permanent magnet, with an added or integral bobbin or spool forreceiving a copper wiring or windings forming a generator coil) isprovided within a chamber disposed in the appliance body. Inside thechamber/tube portion of the bobbin is a permanent magnet such as a rareearth, neodymium, or other magnet that is bipolarly magnetized at thetop and bottom. The bobbin is wound with copper wire such that when thebobbin travels through the magnetic pathway, a magnetic field changesand based on Faraday's laws regarding induction, causes electricalcurrent to flow in the wires of the copper coil/windings to charge theelectrically connected rechargeable battery.

When provided in an intra-oral appliance, the hearing assist device 60may further include an extrabuccal transmitter that can include amicrophone for receiving sounds, and which is electrically connected toa processor for processing the auditory signals. With respect tomicrophone, a variety of various microphone systems may be utilized. Forinstance, microphone may be a digital, analog, and/or directional typemicrophone. Such various types of microphones may be interchangeablyconfigured to be utilized with the assembly, if so desired. Thetransmitter signals may be in any wireless form utilizing, e.g., radiofrequency, ultrasound, microwave, Blue Tooth™ (BLUETOOTH SIG, INC.,Bellevue, Wash.), etc. The intra-oral appliance may also optionallyinclude one or more input controls that a user may manipulate to adjustvarious acoustic parameters of the electronics and/or transducer, suchas acoustic focusing, volume control, filtration, muting, frequencyoptimization, sound adjustments, and tone adjustments, etc. In certainembodiments, such controls may be located on a surface of the intra-oralappliance such that the controls may be manipulated by the subject'stongue during use. Alternatively or in addition thereto, the controlsmay be provided in a separate housing for wireless control thereof bythe subject.

When present, the hearing assist device 60 of the intra-oral appliancemay also be configured to serve as an inter-oral communications deviceto wirelessly control and/or communicate with other electronic devices(see, e.g., U.S. Pub. No. 2013/0278396, incorporated by reference in itsentirety). As described above, the intra-oral appliance may include apower device, which can power the apparatus, a memory storage device,which can store and recall data; a communications subsystem, whichcommunicates with one or more remote devices; an output device, whichcreates stimulus directly or indirectly observable in the mouthenvironment; an input device, which can create signals according toactivity in the mouth environment and can send them to the memorystorage device and/or processor; and a processor coupled to the memorystorage device, the communication subsystem, the output device and theinput device.

Referring now to FIGS. 2E and 2F, there is shown an embodiment ofintra-oral Appliance A with an embedded hearing assist device 60. Asdescribed above with reference to FIGS. 2A and 2B, Appliance A includesan appliance body 22 fitted over the upper teeth 11 of a human maxilla10, and therefore like numerals will be omitted for clarity. The hearingassist device 60 may be embedded within the appliance body 22 duringmolding thereof, and positioned so as to provide hearing assistancethrough bone conduction, as described above. Likewise, FIGS. 2G and 2Hshow embodiments of intra-oral Appliance A (as shown in FIGS. 2C and 2D)with a pair of embedded hearing assist devices 60, for use when thesubject is afflicted with bilateral facial palsy as well as bilateralacoustic neuroma.

Referring now to FIGS. 3D and 3E, there is shown an embodiment ofintra-oral Appliance B having a hearing assist device 60 embedded withinthe appliance body 32. As discussed above with reference to FIGS. 3A and3B, the appliance body 32 may be generally configured like a prior artorthodontic retainer, and can be made of hard or soft plastic or othersuitable materials. The hearing assist device 60 may be embedded withinthe appliance body 22 during molding thereof, and positioned so as toprovide hearing assistance through bone conduction, as described above.FIG. 3F shows an embodiment of Appliance B (FIG. 3C) with a pair ofembedded hearing assist devices 60, for use when the subject isafflicted with bilateral facial palsy as well as bilateral acousticneuroma.

Although the invention has been described with reference to the aboveappliances, it will be understood that modifications and variations areencompassed within the spirit and scope of the invention. Accordingly,the invention is limited only by the following claims.

We claim:
 1. An intra-oral appliance for correcting facial features of asubject, the appliance comprising an appliance body configured forengagement with a subject's upper teeth and anterior palate, wherein theappliance body has one or more extensions for engaging one or more ofthe gingival-buccal area and the vestibular area of the subject's mouth,thereby at least partly defining a cavity in the vestibule of thesubject's mouth.
 2. The intra-oral appliance of claim 1, wherein theappliance body has one extension for defining the vestibule at eitherside of the subject's mouth.
 3. The intra-oral appliance of claim 1,wherein the appliance body has two extensions for defining the vestibuleat both sides of the subject's mouth.
 4. The intra-oral appliance ofclaim 1, further comprising one or more dentures disposed in theappliance body.
 5. The intra-oral appliance of claim 1, furthercomprising one or more hearing assist devices embedded in the appliancebody.
 6. An intra-oral appliance for correcting facial features of asubject, the appliance comprising an appliance body configured forengagement with the subject's upper gingiva on the afflicted side thesubject's face, wherein the first appliance body is positioned from themaxillary midline of the subject's upper gingiva to the farthest upperposterior tooth or edentulous buccal portion, wherein the appliance bodyhas one or more extensions for engaging one or more of the uppergingival-buccal area, the upper gingivolabial area, and the uppervestibular area of the subject's mouth.
 7. The intra-oral appliance ofclaim 6, further comprising one or more dentures disposed in theappliance body.
 8. The intra-oral appliance of claim 6, furthercomprising one or more hearing assist devices embedded in the appliancebody.
 9. A system for correcting facial features of a subject afflictedwith facial paralysis on one or both sides of the face, comprising: a)an upper intra-oral appliance comprising a first appliance bodyconfigured for engaging one or more of the upper gingival-buccal area,the upper gingivolabial area, and the upper vestibular area of thesubject's mouth; and b) a lower intra-oral appliance comprising a secondappliance body configured for engaging one or more of the lowergingival-buccal area, the lower gingivolabial area, and the lowervestibular area of the afflicted side the subject's face.
 10. The systemof claim 9, wherein the first appliance body is configured forengagement with the subject's upper teeth and anterior palate, whereinthe first appliance body has one or more extensions for engaging one ormore of the upper gingival-buccal area, the upper gingivolabial area,and the upper vestibular area of the subject's mouth.
 11. The system ofclaim 9, wherein the first appliance body is configured for engagementwith the subject's upper gingiva on the afflicted side the subject'sface, wherein the first appliance body is positioned from the maxillarymidline of the subject's upper gingiva to the farthest upper posteriortooth or edentulous buccal portion.
 12. The system of claim 9, whereinthe first appliance body is configured for engaging the upper gingivawhere the tooth crown meets the gum line.
 13. The system of claim 9,wherein the second appliance body is configured for positioning from themandibular midline of the subject's lower gingiva and teeth to thefarthest lower posterior tooth or edentulous buccal portion of the jaw.14. The system of claim 9, further comprising a third intra-oralappliance comprising a third appliance body configured for engagementwith the subject's upper gingiva on the afflicted side the subject'sface, wherein when used, the third appliance body is positioned from themaxillary midline of the subject's upper gingiva to the farthest upperposterior tooth or edentulous buccal portion, and wherein the first andthird intra-oral appliances are not used simultaneously.
 15. The systemof claim 9, wherein the first appliance body, second appliance body, orboth the first and second appliance bodies further comprise one or moredentures disposed therein.
 16. The system of claim 9, wherein the firstappliance body, second appliance body, or both the first and secondappliance bodies further comprise one or more hearing assist devicesembedded therein.
 17. A system for correcting facial features of asubject afflicted with facial paralysis on one or both sides of theface, comprising: a) a first upper intra-oral appliance comprising afirst appliance body configured for engagement with the subject's upperteeth and anterior palate, wherein the first appliance body has one ormore extensions protruding from an area corresponding to the uppergingiva of the subject for engaging one or more of the uppergingival-buccal area, the upper gingivolabial area, and the uppervestibular area of the subject's mouth; b) a second upper intra-oralappliance comprising a second appliance body configured for engagementwith the subject's upper gingiva and buccal dentition on the afflictedside the subject's face, wherein the second appliance body is positionedfrom the maxillary midline of the subject's upper gingiva to thefarthest upper posterior tooth or edentulous buccal portion, and whereinthe second appliance body has one or more extensions protruding from anarea corresponding to the upper gingiva of the subject for engaging oneor more of the upper gingival-buccal area, the upper gingivolabial area,and the upper vestibular area of the subject's mouth; and c) a lowerintra-oral appliance comprising a third appliance body configured forengagement with the subject's lower gingiva and buccal dentition on theafflicted side of the subject's face, wherein the third appliance bodyhas one or more extensions protruding from an area corresponding to thelower gingiva of the subject for engaging one or more of the lowergingival-buccal area, the lower gingivolabial area, and the lowervestibular area of the afflicted side the subject's face, wherein thefirst upper intra-oral appliance and the second upper intra-oralappliances are not used simultaneously.
 18. The system of claim 17,wherein the first appliance body, second appliance body, third appliancebody, or any combination thereof further comprise one or more denturesdisposed therein.
 19. The system of claim 17, wherein the firstappliance body, second appliance body, third appliance body, or anycombination thereof further comprise one or more hearing assist devicesembedded therein.
 20. A method for correcting facial features and oralfunction of a subject comprising fitting a subject in need thereof with:a) an upper intra-oral appliance comprising a first appliance bodyconfigured for engaging one or more of the upper gingival-buccal area,the upper gingivolabial area, and the upper vestibular area of thesubject's mouth; and b) a lower intra-oral appliance comprising a secondappliance body configured for engaging one or more of the lowergingival-buccal area, the lower gingivolabial area, and the lowervestibular area of the afflicted side the subject's face, thereby atleast partly defining the cavity in the vestibule of the subject'smouth.
 21. The method of claim 20, wherein the first appliance body isconfigured for engagement with the subject's upper teeth and anteriorpalate, wherein the first appliance body has one or more extensions forengaging one or more of the upper gingival-buccal area, the uppergingivolabial area and the upper vestibular area of the subject's mouth.22. The method of claim 20, wherein the first appliance body isconfigured for engagement with the subject's upper gingiva on theafflicted side the subject's face, wherein the first appliance body ispositioned from the maxillary midline of the subject's upper gingiva tothe farthest upper posterior tooth or edentulous buccal portion.
 23. Themethod of claim 22, wherein the first appliance body is configured forengaging the upper gingiva where the tooth crown meets the gum line. 24.The method of claim 20, wherein the second appliance body is configuredfor positioning from the mandibular midline of the subject's lowergingival to the farthest lower posterior tooth or edentulous buccalportion.
 25. The method of claim 20, wherein the subject suffers fromfacial paralysis or defect.
 26. The method of claim 20, wherein thefirst appliance body, second appliance body, or both the first andsecond appliance bodies further comprise one or more dentures disposedtherein.
 27. The method of claim 20, wherein the first appliance body,second appliance body, or both the first and second appliance bodiesfurther comprise one or more hearing assist devices embedded therein.28. The method of claim 27, wherein the subject suffers from unilateralor bilateral acoustic neuroma or hearing loss.